Summary of Tenax Therapeutics FY Conference Call Company Overview - **Company**: Tenax Therapeutics (NasdaqCM:TENX) - **Event**: 37th Annual Healthcare Conference - **Date**: December 04, 2025 Key Points Industry and Company Focus - Tenax Therapeutics is focused on developing treatments for pulmonary hypertension, specifically targeting Group 2 patients with heart failure and preserved ejection fraction (HFpEF) [1][19]. Phase III LEVEL Study - The Phase III LEVEL study is on track to read out in the second half of 2026, with a goal to enroll 230 subjects by the first half of 2026 [1][3]. - The sample size was increased from 150 to 230 based on investor support and funding, which is expected to de-risk the study and maintain a 90% power in statistical calculations [5][6]. Study Design and Methodology - The LEVEL study is a 12-week trial, followed by a month for data cleaning and statistical analysis [4]. - An adaptive element called BSSR (Blinded Sample Size Reassessment) allows for adjustments based on interim data analysis once two-thirds of subjects have completed treatment [7][8]. - The study will utilize a six-minute walk test as a primary endpoint, with a clinically meaningful difference set at 25 meters [26]. Mechanism of Action - Levosimendan, the drug under investigation, works through calcium sensitization and potassium channel activation, which helps regulate venous circulation and improve exercise capacity in patients [24][25]. Clinical Data and Efficacy - The Phase II trial was the only successful trial to date, and the company is confident in achieving a treatment effect of 25 meters based on previous data [26][30]. - The six-minute walk test has been established as a valid cardiovascular endpoint, and measures are in place to control placebo responses [31][32]. Future Studies - LEVEL 2 study is planned to be a larger, 26-week trial involving multiple countries, with the same inclusion and exclusion criteria as LEVEL 1 [38][39]. - The FDA has indicated that both studies will provide sufficient safety data for approval [37]. Open-Label Extension (OLE) - Both LEVEL studies will include an open-label extension of up to 104 weeks, ensuring continuity of care for participants [51]. Investor Sentiment - The management expressed optimism about the upcoming year, highlighting the potential catalysts from the ongoing studies [52]. Additional Insights - The company is focused on maintaining a robust study design to ensure the validity of results, particularly in controlling variables that could affect the six-minute walk test outcomes [32][33]. - There is a strategic plan to avoid enrollment cannibalization between LEVEL 1 and LEVEL 2 by introducing new sites for LEVEL 2 [46]. This summary encapsulates the critical aspects of Tenax Therapeutics' conference call, focusing on the company's ongoing studies, drug mechanism, and future plans in the context of the pulmonary hypertension market.

Company Overview - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies using clinical insights [3] - The company owns global rights to develop and commercialize levosimendan, targeting the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension, for which no product has been approved to date [3] - Tenax Therapeutics' common stock is listed on The Nasdaq Stock Market LLC under the symbol "TENX" [3] Upcoming Events - The company will present at the 8th Annual Evercore Healthcare Conference on December 2, 2025, at 4:15 p.m. ET, featuring a fireside chat with Chris Giordano, President & CEO, and Stuart Rich, M.D., Chief Medical Officer [1] - Additionally, Tenax Therapeutics will participate in the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025, at 11:30 a.m. ET, also in a fireside chat format [2] - Live and archived webcasts of these presentations will be accessible from the company's investor relations webpage [2]

Core Insights - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies [3] - The company will present at the Guggenheim Annual Healthcare Innovation Conference from November 10-12, 2025, in Boston, MA [1][2] Presentation Details - The presentation will be in a fireside chat format featuring Chris Giordano, President & CEO, and Stuart Rich, M.D., Chief Medical Officer [2] - Scheduled date and time for the presentation is November 10, 2025, at 4:00 p.m. ET [2] - A live and archived webcast of the presentation will be available on the company's investor relations webpage [2] Company Overview - Tenax Therapeutics owns global rights to develop and commercialize levosimendan, targeting the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension [3] - Currently, there are no approved products for PH-HFpEF, highlighting a significant market opportunity for the company [3] - The company's common stock is listed on The Nasdaq Stock Market under the symbol "TENX" [3]

Core Insights - Tenax Therapeutics has received an Intention to Grant notification from the European Patent Office for a patent that will protect TNX-103 (oral levosimendan) and other formulations for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF) until at least December 2040 [1][2] - The patent will cover various routes of administration and a wide range of doses, as well as the use of levosimendan in combination with other cardiovascular drugs [2][3] - This patent is crucial as the company prepares to initiate its second registrational Phase 3 study, LEVEL-2, which will recruit patients across Europe [2][4] Company Overview - Tenax Therapeutics is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies [4] - The company holds global rights to develop and commercialize levosimendan, targeting PH-HFpEF, which is the most prevalent form of pulmonary hypertension globally [4] - Levosimendan has received market authorization in 60 countries for treating acutely decompensated heart failure, although it is not available in the U.S. or Canada [3]

Company Overview - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies using clinical insights [3] - The company owns global rights to develop and commercialize levosimendan, targeting the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension, for which no product has been approved to date [3] Upcoming Event - Tenax Therapeutics will participate in a fireside chat at the Cantor Global Healthcare Conference 2025, scheduled for September 3-5, 2025, in New York, NY [1] - The presentation will feature Chris Giordano, President & CEO, and Stuart Rich, M.D., Chief Medical Officer, on September 4, 2025, at 10:20 a.m. ET [2] - A live and archived webcast of the presentation will be available on the company's investor relations webpage [2]

Group 1 - Tenax Therapeutics (NASDAQ: TENX) is advancing its drug development plan for levosimendan, currently in phase 3 LEVEL trial [2] - The company is positioned well within the pharmaceutical sector, indicating potential for growth and investment opportunities [2] Group 2 - The Biotech Analysis Central service offers extensive resources for investors, including a library of over 600 biotech articles and a model portfolio of small and mid-cap stocks [2]

Core Insights - Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing novel cardiopulmonary therapies [3] - The company will present at the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025 [1][2] - Tenax Therapeutics is developing levosimendan for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension, for which no product has been approved to date [3] Presentation Details - The corporate presentation will be led by Chris Giordano (President & CEO), Stuart Rich, M.D. (Chief Medical Officer), and Doug Randall (Chief Business Officer) [2] - The presentation is scheduled for April 7, 2025, at 3:45 p.m. ET [2] - A live and archived webcast of the presentation will be available on the company's investor relations webpage [2] Company Overview - Tenax Therapeutics owns global rights to develop and commercialize levosimendan [3] - The company's common stock is listed on The Nasdaq Stock Market LLC under the symbol "TENX" [3]